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Boston Scientific Infusion Ports

Hundreds of patients may need surgery to remove an implanted drug-injection device, the Vaxcel Low Profile Infusion Ports made by Boston Scientific Corp., the company said yesterday after federal regulators cited it for quality-control problems. A spokesman for Boston Scientific said it has been advising doctors to consider surgery if their patients have one of the 1,000 drug-infusion ports it recalled in March. In addition, the company said it will recall another 1,000 ports this week, in response to a warning letter it received May 18 from the Food and Drug Administration about quality-control standards.

The letter, which was posted yesterday on the FDA's website, said Boston Scientific failed to establish manufacturing controls for the quality of the devices and did not properly track quality concerns. The problems could cause the ports to leak drugs into unintended parts of the body, though the company said it knew of only one possible report of a patient injury. The FDA's letter directed the company to fix problems it called ''serious violations of the law" that could result in fines, product seizures, or other penalties.

Infusion ports make it easier to treat cancer patients and others who need frequent drug injections by avoiding repeated needle-sticks directly into a blood vessel. Typically, the ports feature a circular surface made of silicon-like material about the size of a 50-cent piece that is implanted under the skin, often just below the clavicle. Needles poked through the port's surface deliver drugs that flow through a catheter surgically attached to a vein. According to the FDA's letter, Boston Scientific started reviewing its manufacturing procedures Aug. 26 after receiving a complaint that the two plastic pieces that form the port's cover and base had separated, possibly because they weren't correctly welded.

It received at least four more complaints through Feb. 9, and on March 9 launched a voluntary recall of all 1,000 ports it had shipped to date that included valves to stop blood from flowing up from the catheter to the reservoir. At the time, Boston Scientific said it didn't need to recall ports made without valves because the company hadn't received complaints about those models. But the FDA's letter said it did receive a complaint Jan. 5 about a ''leak in the membrane" of a non-valved port.

The company was warned for failing to maintain adequate procedures to identify actions 'to correct and prevent the recurrence of nonconforming product and other quality problems. This technology became widely used by the 1990s.

If you or a loved one suffered injuries from a Boston Scientific Infusion port, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney.